A Study of Nivolumab in Selected Uterine Cancer Patients
| Purpose: | This phase II trial studies how well nivolumab works in treating patients with uterine cancer that has spread to other places in the body or come back after a period of improvement. Monoclonal antibodies, such as nivolumab, may block tumor growth in different ways by targeting certain cells. |
| Authoritative site for this trial: | At clinicaltrials.gov |
| What is the treatment? | Nivolumab treatment: Nivolumab 480 mg IV once every 4 weeks |
| Is there a chance you'll get a placebo? | No, all patients receive treatment. |
| How old do you have to be? | 18 or order |
| What phase study is this? | Phase II (see Glossary) |
| What includes you in trial? | Pathologist confirmed diagnosis (see Glossary) of metastatic or recurrent uterine cancer (endometrial carcinoma, carcinosarcoma, clear cell carcinoma, leiomyosarcoma, undifferentiated sarcoma, high grade endometrial stromal sarcoma) by Memorial Sloan Kettering Cancer Center; Carcinosarcomas, appears to have come from.in the ovary/fallopian tube or coverings (peritoneum) of abdomen are also eligible; If you have a recurrence it should not be treatable by other methods such as surgery or chemotherapy or radiation therapy. Tumor is confirmed to a high burden of mutations (see Glossary) Received prior radiation or chemotherapy t for advanced disease (hormonal therapy is not considered to count as prior therapy) Able to move around and basic self care No known metastases to the brain Approximately normal heart, lung and liver function Your blood counts are at least near normal (or can be normalized by short-term treatment including transfusion) Your tumor tissue is available (either from pathologist or from a new biopsy) If you are of child-bearing age, you will have to be first tested for pregnancy and have a negative pregnancy test and then use contraceptives throughout treatment. |
| What excludes you from the trial? | You are eligible for potentially curative treatment with standard chemotherapy, surgical resection, or chemo-radiotherapy If you have known or suspected autoimmune disease (unless the autoimmune disease is vitiligo, diabetes mellitus, resolved childhood asthma/atopy, hypothyroidism , psoriasis not requiring oral/IV treatment in which case you are not excluded) Serious uncontrolled diseases or active infection which would get in the way of the potential effect of this treatment. Serious bowel problems in the last 3 months (Including ascites and Prior treatment that is antibody-based (e.g. anti-PD1 antibodies). History of other cancers (exceptions: cancer of skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, or in situ carcinoma of the uterine cervix, prostate, or breast). If you do have a history of other cancers, you are not excluded if you achieved full remission over 3 years ago. Breastfeeding women, pregnant women Prisoners or people held for treatment or protection (eg. psychiatric diseases) Hepatitis or HIV infection Known allergy or adverse drug reaction to nivolumab, or a history of allergy to study drug components |
| In USA? | Yes |
| Sites where the trial is offered: | New Jersey and New York (see Contact Information for specific sites) |
| Contact information: | New Jersey Basking Ridge Memorial Sloan Kettering Basking Ridge Contact: Claire F. Friedman Phone: 646-888-4221 Middletown Memorial Sloan Kettering Monmouth Contact: Claire F. Friedman Phone: 646-888-4221 Montvale Memorial Sloan Kettering Bergen Contact: Claire F. Friedman Phone: 646-888-4221 New York Commack Memorial Sloan Kettering Commack Contact: Claire F. Friedman Phone: 646-888-4221 Memorial Sloan Kettering Cancer Center Contact: Claire F. Friedman Phone: 646-888-4221 Rockville Centre Memorial Sloan Kettering Rockville Centre Contact: Claire F. Friedman Phone: 646-888-4221 West Harrison Memorial Sloan Kettering Westchester Contact: Claire F. Friedman Phone: 646-888-4221 |